A Model for an Academia-Industry Collaboration for Pharmacovigilance and
Pharmacoepidemiology
Abstract
Purpose We describe a novel model for collaboration between
academia and the pharmaceutical industry, focused on post-marketing
pharmacovigilance. Methods Otsuka Pharmaceutical, a global
Japan-based pharmaceutical company, and Columbia University, a major
university, have established a collaboration dedicated to working
together in pharmacoepidemiology and post-marketing pharmacovigilance.
An oversight committee, made up of individuals from each institution,
meets on a regular basis to set policy and provide oversight.
Results The primary aim of this novel academia-industry
collaboration is to provide expert research guidance for the industry
pharmacovigilance group on questions involving pharmacoepidemiology.
University epidemiologists may also be consulted by other divisions of
industry, such as the clinical trials group. The first aim of the
collaboration is to provide epidemiologic input to industry by
determining the incidence, prevalence, and outcomes of diseases;
drafting the epidemiology components of risk management plans for drugs;
and planning retrospective database analyses. A second major aim is to
provide educational services to industry by conducting workshops on
basic epidemiology and biostatistics; leading a monthly lecture/journal
club series; hosting seminars on medical topics; and providing a writing
workshop to assist in preparing abstracts and papers for presentation
and publication. University epidemiologists provide oversight/evaluation
through quarterly presentations and updates to the industry partner’s
external advisory committee as well as to University leadership.
Conclusions This unique academia-pharmaceutical industry
collaboration enhances understanding of the medical and epidemiologic
challenges faced within a pharmacovigilance department of a global
pharmaceutical company. We offer it as a model for others performing
mandatory regulatory post-marketing pharmacovigilance activities.